Audit and Quality Specialist

Would you like to take the next exciting step in your career by playing a key role in a dynamic and impactful business support unit, driving meaningful change in Local Manufacturing production? Does using your hands-on expertise within Audits, QMS and cGMP to tackle tasks, enhance processes, and elevate our quality standards inspire you? Are you passionate about influence and defining the right quality level, coaching and guiding colleagues, and herby influencing quality decisions on a global scale?

Then you might be our new Audit and Quality Specialist in our office in Bagsværd! Apply today for a life-changing career!

The Position

In your role as our Audit and Quality Specialist, you will serve as a reliable business partner for the area. This includes providing support through sparring, conducting Mock audits, and addressing various quality and compliance issues in close collaboration with the QA team.

You will be at the forefront of our operations, and your expertise within Good Manufacturing Practice (GMP) will greatly influence our direction. Your contributions will be pivotal in guiding our daily activities and providing support to our local production sites.

Even though we are office based, some travel activities can be expected based on organizational objectives and respond to urgent needs.

The main tasks will be to:

• Be responsible for audit program at Local Manufacturing (LM), ensuring internal audit readiness, by preparing and potentially executing mock-audits at LM Sites.

• Drive the implementation and continual improvement of LM QMS in an appropriate manner to gain agility, simplicity, efficiency, while maintaining high quality standards and meeting cGMP requirements and expectations.

• Ensure adherence to GMP compliance requirements and best practices sharing across all operations in LM.

• Guide and instruct stakeholders on GMP and QMS regarding how and what to implement in a local setting.

• Represent LM in corporate Process Groups and establish LM network for relevant process groups with Audit and Quality processes.

• Supporting local sites by being the “Scandinavian Door” into the larger NN organization, helping with solving Quality issues, providing guidance and facilitating support from other parts of the organization.

Qualifications

To succeed in this role, you have:

• A minimum of a Bachelor’s degree in natural sciences, chemistry, pharmacy or similar field.

• Minimum +6 years of GMP experience from the pharmaceutical industry, such as tablets, assembly or packaging of finished products.

• Experience within Audits and inspections, preferable as lead Auditor.

• Full professional proficiency in English, while having proficiency in Danish is nice to have.

As a person, you have strong stakeholder management skills and can set clear direction within GMP, Quality mindset and behaviour. Being a strong team player, who can easily build relationships and partnerships is crucial in this role.

We will welcome a colleague who is proud of having great communication skills, the ability to understand and act within foreign cultures, while also fostering teamwork, knowledge sharing and collaboration across our global organization.

About the Department

Local Manufacturing - Projects and site Support, is part of LM Business Support, Denmark and our primary role is the establishment and operation of local manufacturing sites in countries where local presence is required to obtain market access.

We are overseeing our local production sites in Algeria, Russia, Iran, and Japan and provide quality, compliance and project support to our local factories on a daily basic.

The Project and Site Support team consists of specialists, professionals and project managers, providing support and guidance within Quality, Audit and Inspections and Production Processes (FPM).

We have high ambitions and aim, as a team, to raise the quality and performance level at our Local Sites.

We are 23 employees in the entire department in Denmark and we are currently located in Bagsværd but will relocate to site Høje-Tåstrup during Q4/2025.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact

For further information, please contact Senior Manager Projects and Site support Karin Løbel-Moberg at +45-34442643 or via email at .

Deadline

26 May 2025

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.